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Study and Treatment of Inflammatory Muscle Diseases - Article


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Autoimmune Diseases (General)


Clinical Trial: Study and Treatment of Inflammatory Muscle Diseases

This study is currently recruiting patients.

Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: Warren G Magnuson Clinical Center (CC)

Purpose

This study of inflammatory muscle diseases-polymyositis and dermatomyositis and related disorders-will examine what causes these diseases and describe the clinical features (signs and symptoms) associated with them. Inflammation and degeneration of skeletal muscles in these disorders leads to weakness and muscle wasting. The skin, lungs and other organs may also be involved.

Patients 16 years of age and older with polymyositis, dermatomyositis, or a related disorder may be eligible for this study. Participants will undergo a complete history and physical examination, including routine blood and urine tests. Additional procedures for diagnosis, treatment or research may include:

1. Blood sample for genetic studies.

2. Muscle biopsy-removal of a tissue sample for microscopic examination. Under local anesthetic, a 1/2- to 1-inch long incision is made in the thigh or upper arm, and a small piece of muscle is removed.

3. Electromyography-measurement of the electrical activity of a muscle. A needle is inserted through the skin into a muscle to record its electrical activity.

4. Magnetic resonance imaging-visualization of organs or tissues, using a magnetic field and radio waves. The patient lies on a table inside a narrow cylinder (the MRI scanner) with a strong magnetic field for the scanning.

5. Manual muscle strength testing by a physiotherapist.

6. Swallowing studies using ultrasound (imaging using sound waves) and X-rays (barium swallow) to evaluate swallowing and speaking abilities.

7. Questionnaires on swallowing ability and ability to perform daily living activities

8. Pulmonary function tests-measurement of movement of air in and out of the lungs. The patient breathes into a machine to evaluate lung function.

9. Chest X-rays to evaluate lung function.

10. Electrocardiogram and, if necessary, Holter monitoring (measurement of the electrical activity of the heart) and echocardiogram (ultrasound imaging of the heart) to evaluate heart function.

11. Apheresis-collection of white blood cells for research. Whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The white cells are removed and the rest of the blood is returned to the body through the same needle or through a second one placed in the other arm.

12. MR guided muscle biopsy-measurement of glycogen in muscle tissue using magnetic resonance imaging. Certain patients may undergo this experimental procedure to compare MRI findings with those of muscle biopsy. The affected muscles are identified using MRI and the biopsy incision is made. MRI is then used to guide the biopsy needle to the muscle and a small piece is removed.

Patients who are eligible for experimental treatment studies will be offered the opportunity to join them. Others will be advised of treatment recommendations.

Condition
Autoimmune Disease
Dermatomyositis
Inclusion Body Myositis
Myositis
Polymyositis

MedlinePlus related topics:  Autoimmune Diseases;   Myositis

Study Type: Observational
Study Design: Natural History

Official Title: Studies on the Natural History and Pathogenesis of Polymyositis, Dermatomyositis, and Related Diseases

Further Study Details: 

Expected Total Enrollment:  9999

Study start: August 6, 1991

Polymyositis, dermatomyositis and related disorders, also known as the idiopathic inflammatory myopathies (IIM), are an uncommon, heterogenous group of diseases. This is an omnibus protocol designed to continue our description of this rare group of diseases, further delineate important groups of patients, and obtain useful material for further study on the immunological abnormalities, pathogenesis and etiology of IIM. Often the diagnosis of an IIM can be confused with other illness (such as adult-onset dystrophies), and therefore, we will be evaluating patients with other illnesses (who are referred with a preliminary diagnosis of an IIM). Patients evaluated with IIM will receive with informed consent the best standard therapies available and consideration for entry into any therapeutic protocols. MRI will be performed on healthy volunteers to help develop a mathematical method for quantitating edema of muscle MRI in patients.

Eligibility

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

INCLUSION CRITERIA:
Patients with known or suspected idiopathic inflammatory myopathies (IIM) or patients with other connective tissue diseases with weakness or myalgias for an inflammatory myopathy or other muscle process.

Location and Contact Information


Maryland
      National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting
Patient Recruitment and Public Liaison Office  1-800-411-1222    prpl@mail.cc.nih.gov 
TTY  1-866-411-1010 

More Information

Detailed Web Page

Publications

Bohan A, Peter JB. Polymyositis and dermatomyositis (first of two parts). N Engl J Med. 1975 Feb 13;292(7):344-7. Review. No abstract available.

Plotz PH, Dalakas M, Leff RL, Love LA, Miller FW, Cronin ME. Current concepts in the idiopathic inflammatory myopathies: polymyositis, dermatomyositis, and related disorders. Ann Intern Med. 1989 Jul 15;111(2):143-57. Review.

Study ID Numbers:  910196; 91-AR-0196
Record last reviewed:  June 18, 2004
Last Updated:  November 23, 2004
Record first received:  November 3, 1999
ClinicalTrials.gov Identifier:  NCT00001265
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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September 6, 2008



Page Updated: September 6, 2005
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